Principal Statistical Programmer
A privately held pharma-company is advertising a vacancy for an Associated Principle Scientist - Toxicology, based in their office in Switzerland. The company is active in the life sciences areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools, and investment management, and focuses on innovative treatments, such as in oncology with a focus on solid tumours, as part of their business. This is an exciting opportunity to work with a leading pharmaceutical organization and support their R&D operations to create new, viable treatments.
- Responsible for the scientific aspects of clinical pharmacology assessments in oncology trials of assigned projects, including pharmacometrics (PK, PK/PD, Exposure/Response), management of drug-drug interactions, and QT prolongation risk evaluation;
- Responsible for assigned clinical pharmacology studies from conception to final report, including first-in-human studies (SAD, MAD), bioequivalence, food effect, drug-drug interactions, TQT, special populations PK, and ADME studies.
- Collaborating with Medical Science, Translational Science, Clinical Safety, Data Management & Biostatistics, Clinical Operations, and Regulatory functions to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
- Determining, in collaboration with the relevant functions within Research & Development, clinical dose selection and dose adjustment.
- Authoring and reviewing documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs.
- Identifying, overseeing, and managing external vendors and consultants, supporting the clinical pharmacology function.
- Liaising with KOLs and academic collaborators on state-of-the-art clinical pharmacology science and methodology.
- Identifying and communicates potential project hurdles, suggesting solutions, and establishing priorities and contingency plans.
- Ensuring the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology.
Skills and Requirements:
- Educated to degree level in a relevant discipline and/or equivalent work experience.
- Advanced knowledge of SAS programming techniques.
- Extensive knowledge and understanding of the programming and reporting process.
- Good knowledge of SOPs/Guidelines, ICH-GCP, & any other applicable local & international regulations such as 21 CFR Part 11.
- Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated.
- Ability to learn new systems and function in an evolving technical environment.
- Proven record of successfully leading teams in a statistical programming environment.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Magenis at +44 203 854 1050 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.